Immuno-oncology
The TCR therapy showed strong efficacy and durability in patients with previously treated melanoma. A Phase III pivotal trial is due to start in December.
PD-1 inhibitor Opdivo has obtained US FDA approval for pre- and post-surgical treatment in operable non-small cell lung cancer, but Merck and AstraZeneca got there first.
The biotech is cutting jobs and discontinuing development of its anti-CD47 bispecific for blood cancers and moving its focus to SL-325, which targets the TL1A-DR3 axis in autoimmune diseases.
New data from CARTITUDE-4 show a survival benefit in patients with lenalidomide-refractory patients as early as the second line, along with Carvykti being studied for frontline use.
Nine months after Bristol Myers Squibb’s LAG-3/PD-L1 combination Opdualag failed a Phase III trial in microsatellite stable metastatic colorectal cancer, Merck & Co's fixed-dose combo of favezelimab and Keytruda has suffered the same fate in the indication.
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
Gilead’s divestment from a 50-50 joint venture with local partner, which came to light recently, will leave China’s cell therapies market under the total control of domestic players in the coming years.
The company’s investment in oncology is starting to pay off, with its PD-L1/VEGF inhibitor BNT324 generating particular interest at ESMO.
Phase II data at the ESMO meeting showed promising efficacy for the drug beyond NSCLC, particularly in certain indications of colorectal and head-and-neck cancers.
AstraZeneca’s NIAGARA trial of perioperative Imfinzi in bladder cancer was positively received at the ESMO meeting but its design did not distinguish the contributions of each treatment portion to the overall effect – something that the US FDA is likely to have a view on.
Merck & Co has presented lots of data on its huge-earning checkpoint inhibitor at the Barcelona congress, the highlights being impressive first-time overall survival results for Keytruda in cervical cancer and early-stage triple-negative breast cancer.
Persistence has paid off for Incyte’s Zynyz in anal cancer with a Phase III win that should make up for a previous disappointment at the FDA and give a boost to the firm’s pipeline prospects for a post-Jakafi era.
While oncology heavyweights Roche and Merck & Co have failed to make much headway with their in-house TIGIT offerings, hopes are high for iTeos's belrestotug in combination with GSK's checkpoint inhibitor, Jemperli, which has demonstrated promising response rates for non-small cell lung cancer in the Phase II GALAXIES Lung-201 study.
The US company believes it can not only beat Keytruda at its own game, but also achieve success where Merck & Co's blockbuster and other immunotherapies have failed.
Ivonescimab has shown significant and "extremely commercially meaningful" improvements in progression-free survival versus Keytruda as a first-line therapy for lung cancer in a trial in China, potentially positioning it as a new chemo-free solution for all PD-L1-positive patients in this setting.
Attendees at this year's European Society for Medical Oncology meeting in Barcelona can look forward to a range of interesting datasets, from Phase III trials of established products in new settings to preliminary studies of novel products coming through the pipeline.
Highlights will include data for Summit/Akeso’s PD-L1/VEGF bispecific versus Keytruda, ADCs and DLL3-targeting drugs for SCLC, and agents against EGFR, HER2 and Trop-2 in NSCLC.
Akeso's CEO has highlighted favorable hazard ratio results for the Chinese biotech's anti-PD-1/VEGF bispecific antibody ivonescimab in a head-to-head trial with Keytruda across Chinese NSCLC patients with positive PD-L1 expression in a first-line setting.
Merck & Co. is stopping a combo study of Keytruda and radiotherapy in lung cancer and a monotherapy melanoma study, but 1,600 ongoing trials remain.
An option fee from potential program acquirer TuHura has enabled Kineta to resume enrolling a Phase I/II study of a VISTA-targeted antibody that the company thinks has best-in-class potential.